BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8166044 · Received December 14, 2018

    Report

    Report Number
    2210968-2018-77774
    Event Type
    Injury
    Date Received
    December 14, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (MERSILENE TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (MERSILENE TAPE) USED IN THIS PROCEDURE? CITATION: ISRN OBSTETRICS AND GYNECOLOGY. 2013; 5. DOI: HTTP://DX.DOI.ORG/10.1155/2013/843158. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "OUTCOME OF LATE SECOND TRIMESTER EMERGENCY CERCLAGE IN PATIENTS WITH ADVANCED CERVICAL DILATATION WITH BULGING AMNIOTIC MEMBRANES: A REPORT OF SIX CASES MANAGED AT THE DOUALA GENERAL HOSPITAL, CAMEROON." AUTHOR: THOMAS OBINCHEMTI EGBE, THEOPHILE NANA NJAMEN, GREGORY HALLE EKANE, JACQUES KAMGAING TSINGAING, CHARLOTTE NGUEFACK TCHENTE, GERARD BEYIHA, ESTHER BARLA, AND ERNEST NYEMB. CITATION: ISRN OBSTETRICS AND GYNECOLOGY. 2013; 5. DOI: HTTP://DX.DOI.ORG/10.1155/2013/843158. THE PURPOSE OF THE STUDY WAS TO SHOW THE FEASIBILITY OF EMERGENCY LATE SECOND TRIMESTER CERCLAGE WITH ADVANCED CERVICAL DILATATION AND BULGING OF AMNIOTIC MEMBRANES. THIS WAS A RETROSPECTIVE STUDY OF CASE FILES OF PATIENTS WHO UNDERWENT EMERGENCY LATE SECOND TRIMESTER CERCLAGE WITH ADVANCED CERVICAL DILATATION, SOME WITH BULGING OF FETAL MEMBRANES BETWEEN JUNE 2003 AND JUNE 2010. A TOTAL OF 6 PATIENTS (AGE RANGE: 22 TO 35 YEARS OLD) UNDERWENT LATE SECOND TRIMESTER CERVICAL CERCLAGE BETWEEN 24 AND 26 WEEKS OF GESTATIONAL AGE. DURING THE SURGICAL PROCEDURE, THE BLADDER WAS MOBILIZED CEPHALAD WITH SUBMUCOSAL PLACEMENT OF A MERSILENE BAND (ETHICON) ANTERIOR TO POSTERIOR BILATERALLY AT THE LEVEL OF THE INTERNAL OS, TYING POSTERIORLY AND BURYING THE ANTERIOR KNOT. REPORTED COMPLICATIONS INCLUDED PRETERM PREMATURE RUPTURE OF MEMBRANES (N-2) WHICH REQUIRED UNDO STITCHING CHORIOAMNIONITIS (N-2) WHICH REQUIRED UNDO STITCHING. THE AUTHORS RECOMMENDED THAT SALVAGE CERVICAL CERCLAGE SHOULD BE CONSIDERED IN PATIENTS WITH ADVANCED CERVICAL DILATATION AND BULGING MEMBRANES IN THE SECOND TRIMESTER. DESPITE OVERALL POOR PROGNOSIS IN SUCH CASES, SUCCESSFUL OUTCOMES MAY BE OBTAINED IN SELECTED CASES ESPECIALLY WHEN BULGING OF MEMBRANES HAS OCCURRED NO LATER THAN 24 HOURS AND IN THE ABSENCE OF MATERNAL VAGINAL INFECTION. THE AUTHORS RECOMMEND FACILITY BASED INTRODUCTION OF ULTRASOUND SCANNING FOR THE DIAGNOSIS OF THE SHORT CERVIX AND CLINICAL RISK FACTORS FOR CERVICAL INSUFFICIENCY IN ORDER TO FIGHT AGAINST THE POOR MORBIDITY/MORTALITY RELATED TO THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004392 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention